Role of MRI and PET CT for radiotherapy planning for head and neck cancer

Not Applicable

Completed

• Conditions: Radiotherapy for head and neck cancer; Cancer; Head and neck cancer

• Registration Number: ISRCTN34165059
• Lead Sponsor: eeds Teaching Hospitals NHS Trust

Brief Summary

2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25885109 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26530182 results 2016 Results article in https://doi.org/10.1120/jacmp.v17i4.6051 (added 07/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-05-07
• Study Start: 2015-02-02
• Last Update Posted: 20 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Age =18 years old
2. WHO performance status 0-2
3. Histologically proven squamous cell carcinoma of the head and neck region
4. Clinical decision made to proceed with a course of radiotherapy of curative intent of 66-70Gy in 33-35 fractions over 6.5–7 weeks with or without concurrent chemotherapy
5. Measurable primary tumour and/or locoregional metastatic lymph nodes on preradiotherapy imaging
6. Able to provide written informed consent
7. Able to lie flat for 1 hour
8. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal

Exclusion Criteria

1. Hypersensitivity to fluorine-18 FDG
2. Hypersensitivity to iodinated contrast media or gadolinium
3. Poorly controlled diabetes
4. Acute renal failure or moderate renal impairment (estimated glomerular filtration rate < 30 mL/min)
5. Contraindication to MRI imaging, including cardiac pacemaker or presence of MRI incompatible metalwork
6. Claustrophobia precluding MRI imaging
7. Uncontrolled pain
8. Urinary incontinence
9. Female patients must not be pregnant
10. Breastfeeding
11. Serious psychiatric comorbidity

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Accuracy of imaging with a 18FDG-PET-CT and MRI for identification of head and neck<br> tumours for radiotherapy planning, assessed with intraobserver and interobserver comparison of delineation of tumour target by radiologists and radiation oncologists using PET, MRI and CT imaging; analysis will be done when recruitment is complete<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. To determine whether CT scan routinely used to plan radiotherapy can be accurately merged with an MRI scan<br> 2. To determine the feasibility of performing MRI and PET-CT imaging during a course of radiotherapy<br> 3. To identify the most useful timepoints for imaging during radiotherapy to track tumour changes<br> 4. To determine whether changes on MRI and PET-CT taken during radiotherapy could be used to improve the radiotherapy plan during treatment<br><br> These endpoints will be evaluated with quantitative contour comparison tools. Analysis will be done when recruitment is complete.<br>